Surgical access device comprising internal retractor

ABSTRACT

Devices, methods, and systems provide a surgical access device comprising an internal retractor device integrated with or coupled to a body wall or wound retractor. The wound retractor retracts an opening in a body wall into a body cavity, while the internal retractor permits a user to control the positions of internal structures within the body cavity, thereby permitting a user to define a surgical field. Embodiments of the internal retractor are adjustable.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. application Ser. No.15/844,336, filed Dec. 15, 2017, which claims the benefit of U.S.application Ser. No. 13/909,669, filed Jun. 4, 2013, which claims thebenefit of U.S. application Ser. No. 12/840,989, filed Jul. 21, 2010,which claims the benefit of U.S. Application No. 61/227,206, filed Jul.21, 2009, the disclosures of which are incorporated by reference intheir entirety.

BACKGROUND Technical Field

The present disclosure is generally directed to surgical devices, andmore specifically, to a surgical access device comprising a woundretractor and an internal retractor.

Description of the Related Art

Abdominal surgical procedures often entail entry into a patient'sabdominal cavity and subsequent manipulation of internal structurestherein, such as the small intestine, colon, mesentery, and other fattystructures. For example, large portions of a patient's small intestineare often displaced to provide clear access to the patient's spleen insome surgical procedures thereon. Gauze pads and/or sponges are oftenused to dam-up the displaced structures. Pads and/or sponges often slipand/or are difficult to place, however, especially through smallerincision sites. The pads and/or sponges are also typically carefullyaccounted for during surgery, thereby preventing one from being leftbehind within the patient.

Recent abdominal surgical procedures prefer smaller incisions, forexample, laparoscopic surgeries. Laparoscopic surgical procedures ofteninvolve multiple small incisions of from between about five millimetersto about twelve millimeters. Some more complex procedures include alarger single incision. For instance, a five centimeter incision at theumbilicus that is circumferentially retracted by a circular woundretractor accommodates several laparoscopic instruments at the sametime, or even a surgeon's hand extending into the abdominal cavity.Maintaining a clear operative area within the abdominal cavity whilelimiting the access area is desirable.

Additionally, surgical procedures of the lower abdomen and pelvis arealso performed using single-incision techniques, in which a clear,unrestricted working space is also desirable.

SUMMARY OF THE INVENTION

Devices, methods, and systems provide a surgical access devicecomprising an internal retractor device integrated with or coupled to abody wall or wound retractor. The wound retractor retracts an opening ina body wall into a body cavity, while the internal retractor permits auser to control the positions of internal structures within the bodycavity, thereby permitting a user to define a surgical field.Embodiments of the internal retractor are adjustable.

Some embodiments provide surgical access device comprising: a woundretractor comprising an outer ring, an inner ring, and a tubular sheathextending between the outer ring and the inner ring; and an internalretractor coupled to the wound retractor in an operative state of thesurgical access device, the internal retractor comprising a deformableframe, wherein in the operative state, at least a portion of theinternal retractor extends distally of the inner ring.

In some embodiments, the outer ring of the wound retractor is rotatablearound an annular axis thereof, thereby permitting adjustment of aneffective length of the tubular sheath between the inner ring and theouter ring.

In some embodiments, the internal retractor and the wound retractor areintegrated. In some embodiments, the internal retractor is user coupledto the wound retractor in the operative state.

In some embodiments, the internal retractor further comprises aconnection member, wherein the connection member couples the internalretractor to the wound retractor. In some embodiments, the internalretractor comprises at least one of a flexible cover and a dam portion.In some embodiments, the internal retractor comprises at least onewindow therethrough.

In some embodiments, the internal retractor defines a generallyrectangular or nonrectangular shape. In some embodiments, defines agenerally serpentine shape. In some embodiments, the frame comprises atleast one of a lattice, a mesh, a solid sheet, and a perforated sheet.

Some embodiments further comprise a cover disposed over the frame.

In some embodiments, the internal retractor comprises a deformable,planar frame, a cover disposed over the frame, and a connection featurecouplable to the wound retractor.

In some embodiments, the frame comprises a plastically deformablematerial. In some embodiments, the frame comprises an elasticallydeformable material.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a front view of a patient for surgery of the abdomen. FIG. 1Bis a partial front cross section illustrating abdominal content. FIG. 1Cis a partial front cross section of a patient schematically illustratingthe placement of a wound retractor in the abdomen. FIG. 1D is a partialside cross section of a patient illustrating the placement of a woundretractor in the abdomen.

FIG. 2 is a perspective view of an embodiment of an access devicecomprising an internal retractor comprising a plurality of shapeablemembers.

FIG. 3 is a perspective view of another embodiment of an access devicecomprising an internal retractor comprising an inflatable member.

FIG. 4 is a perspective view of another embodiment of an access devicecomprising an internal retractor comprising a fan-like device.

FIG. 5 is a perspective view of another embodiment of an access devicecomprising an internal retractor comprising a shapeable or deformablesupport member.

FIG. 6A is a perspective view of another embodiment of an access devicecomprising a shapeable internal structure in an undeployedconfiguration. FIGS. 6B and 6C are perspective views of the accessdevice illustrated in FIG. 6A in partially deployed configurations. FIG.6D is a perspective view of the access device illustrated in FIG. 6A ina deployed configuration.

FIG. 7 is a perspective view of another embodiment of an access devicecomprising an internal retractor comprising an inflatable, toroidalinternal retractor.

FIG. 8 is a perspective view of another embodiment of an access devicecomprising an internal retractor comprising a radially compressibletube.

FIG. 9 is a perspective view of another embodiment of an access devicecomprising an internal retractor comprising a circumferentiallyserpentine frame defining a tube.

FIG. 10A is a perspective view of another embodiment of an internalretractor comprising a longitudinally serpentine frame defining a tube.

FIG. 10B is a perspective view of the embodiment of FIG. 10A in theundeployed state.

FIG. 10C shows a distal support member engaging the distal end of theinternal retractor of FIG. 10A when deployed.

FIG. 11 is a perspective view of another embodiment of an internalretractor comprising a lattice frame defining a tube.

FIG. 12 is a perspective view of another embodiment an internalretractor comprising a planar, deformable frame.

FIG. 13A is a side view of another embodiment of an access devicecomprising an internal retractor comprising a body couplable to a woundretractor. FIG. 13B is a detail of the internal retractor. FIG. 13C is aperspective view of the body illustrated in FIG. 13A and an extendercouplable to the body.

FIG. 14 is a perspective view of another embodiment an internalretractor comprising a plurality of elongate, shapeable members.

FIG. 15 is a perspective view of another embodiment an internalretractor comprising a plurality of elongate, shapeable members.

FIG. 16A is a partial side cross section of a patient prior to deployingan internal retractor in the abdomen. FIG. 16B is a partial front crosssection and FIG. 16C is a partial side cross section of a patient inwhich an internal retractor has been deployed in the abdomen.

Similar reference characters refer to similar features throughout.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

FIG. 1A is a front view of a patient 10 for surgery of the abdomen 20with an incision site 22 at the umbilicus. FIG. 1B is a partial crosssection illustrating abdominal content 30 confined by a body wall 40,various adhesions, and connections. The content 30 is generally moist,slippery, and difficult to manage, and is especially true for the smallintestine 32. As shown schematically in FIG. 1C and in a partial sidecross section in FIG. 1D, a circular retractor 50 is placed through anincision in the body wall 40 and into an abdominal cavity 42, therebyproviding a surgeon with clear access to the abdominal content 30.

FIG. 2 is a perspective view of an embodiment of a surgical accessdevice 200 comprising a wound retractor 250 and an adjustable internalretractor 270. The wound retractor 250 is disposed at a proximal end 202of the device 200, and the internal retractor 270 is disposed at adistal end 204. A longitudinal axis 206 extends from the proximal end202 to the distal end 204. An access channel 208 extends through thedevice 200.

In the illustrated embodiment, the wound retractor 250 comprises aproximal or outer ring 252; a deformable distal or inner ring 254; and aflexible, tubular sheath 256 disposed between the outer ring 252 and theinner ring 254.

The inner ring 254 is deformable or flexible, which permits a user toinsert the inner ring 254 through an incision or opening in a body wallwith a smaller diameter than a relaxed diameter of the inner ring 254,and into a body cavity. The inner ring 254 is also sufficiently rigid toresist deformation when disposed against an inner surface of the bodywall and under tension by the tubular sheath 256 extending through theincision or opening.

The wound retractor 250 is adjustable or non-adjustable. In theillustrated embodiment, the wound retractor 250 is an adjustable woundretractor. In the illustrated embodiment, the outer ring 252 isrotatable around an annular axis thereof, which winds and/or unwinds thetubular sheath 256 therearound, thereby adjusting an effective length ofthe tubular sheath 256 and a distance between the outer ring 252 and theinner ring 254. This adjustability permits a user to retract an openingor wound in a body cavity. The illustrated outer ring 252 comprises afirst tube 252 a and a second tube 252 b. In other embodiments, theouter ring 252 has another shape, for example, comprising an oval,elliptical, and/or elongated cross section, with a major or longer axiseither parallel with or perpendicular to the longitudinal 206. In someembodiments, the outer ring 252 further comprises one or morecircumferential lumens. In some embodiments, a wire or hoop is disposedin one or more of the lumens. In some embodiments, the wire(s) orhoop(s) is non-compliant. In some embodiments, the wire(s) or hoop(s) isa split hoop.

The outer ring 252, inner ring 254, and tubular sheath 256 independentlycomprise any suitable biocompatible material, for example, one or morepolymer resins. In embodiments in which the outer ring 252 comprises awire or hoop, the wire or hoop comprise at least one of metal, stainlesssteel, spring steel, nitinol, polymer, ceramic, fibers, compositesthereof, and the like.

In some embodiments, the retractor 250 is manufactured in a plurality ofsizes, for example, diameters of at least one of the outer ring 252, theinner ring 256, and sheath 256, and/or length of the sheath 256. Someembodiments of the access device 200 further comprise a cap or lid (notillustrated) couplable to the outer ring 252, which closes and/or sealsthe access channel 208. Some embodiments of the cap or lid permitinstrument and/or hand access through the cap or lid and into the accesschannel 208. Suitable wound retractors, caps, and lids are alsodisclosed in U.S. Pat. Nos. 7,727,146; 7,650,887; and 7,704,207, andU.S. Patent Application Publication No. 2010/0094227 A1, all thedisclosures of which are incorporated by reference.

The internal retractor 270 in the illustrated embodiment is coupled tothe inner ring 254 of the retractor 250 and extends distally of theinner ring 254. In the illustrated embodiment, the internal retractor270 comprises a plurality of a plurality of elongate, shapeable members272, each extending distally from the inner ring 254 of the woundretractor 250. In the illustrated embodiment, each shapeable member 272angles away from the longitudinal axis 206, although in otherembodiments, one or more of the shapeable members 272 extends in adifferent direction, for example, substantially parallel with thelongitudinal axis 206 and/or towards the longitudinal axis 206.

Each shapeable member 272 in the illustrated embodiment comprises anelongate segment and/or wing that comprises any suitable material, forexample, at least one of a polymer resin or metal. Some embodiments ofthe shapeable members 272 comprise an elastically deformable material,for example, metal, stainless steel, spring steel, polymer, fibers, andcombinations thereof. Some embodiments of the shapeable members 272comprise a malleable and/or plastically deformable material, forexample, metal, stainless steel, a super elastic material, a shapememory material, clay, clay-like material, and combinations thereof. Insome embodiments, one or more of the shapeable members 272 is partiallyor completely coated and/or covered with at least one of fabric, gauze,and foam thereby improving traction and/or fluid absorption. In someembodiments, one or more of the shapeable members 272 is partially orcompletely coated and/or covered with a fluid repellant and/or fluidimpermeable material. In some embodiments, one or more of the shapeablemembers 272 comprises a textured and/or non-slip surface. Someembodiments of the shapeable members 272 comprise, for example, wire,strips, sheets, and perforated sheets.

In some embodiments one or more of the shapeable members 272 is curvedalong a transverse axis, thereby stiffening the shapeable members 272using the principle that stiffens a Venetian blind slats. In theillustrated embodiment, at least one of an angle with the longitudinalaxis 206, and a shape of each individual shapeable member 272 isadjustable, thereby retracting structures or organs from, and/orpreventing structures or organs from entering a selected surgical fieldor area, thereby improving access to surgical targets therein. Forexample, in some embodiments, at least a portion of a shapeable member272 is bendable transverse to a local longitudinal axis 274 thereof. Insome embodiments, at least a portion of a shapeable member 272 isbendable or twistable around the local longitudinal axis 274.

In some embodiments, at least one of the shapeable members 272 isintegrated with the inner ring 254. In some embodiments, at least one ofthe shapeable members 272 is separately manufactured, then coupled tothe inner ring 254. For example, some embodiments of the inner ring 254comprise at least one connecting feature to which the shapeable members272 are coupled. In some embodiments, a proximal end of at least oneshapeable member 272 comprises a connecting feature that secures theshapeable member 272 to the inner ring 254 at a desired angle withrespect to the longitudinal axis 206. Suitable connecting featuresinclude, for example, mechanical fasteners, clips, clamps, frictionfittings, hook-and-loop fasteners, snaps, ties, screws, latches, joints,hinges, ball joints, living hinges, and the like. In some embodiments,the shapeable members 272 are coupled to the inner ring 254 as a unit,for example, joined by a web and/or ring at a proximal end of theinternal retractor 270. In some embodiments, shapeable members 272 areindividually coupled to the inner ring 254. In some embodiments, one ormore of the shapeable members 272 are removable as desired, for example,by cutting, breaking off, and the like. In some embodiments, theinternal retainer 270 is removable, for example, after completing aportion of a surgical procedure. Some embodiments of the internalretractor 270 are not coupled to a wound retractor and are usedindependently of the wound retractor.

In the illustrated embodiment, the local axis 274 of each shapeablemember 272 is substantially normal to the inner ring 254. In otherembodiments, the local axis 274 of at least one shapeable member 272subtends another angle with the inner ring 254 in a generally helicalconfiguration. For example, in some embodiments, all of the shapeablemembers 272 together define a helical internal retractor 270.

Some embodiments of the internal retractor 270 further comprise a dam orcover (not illustrated) that is securable to one or more of theshapeable members 272, thereby defining an umbrella-like structure,which improves retraction of internal organs. The cover is similar tothe dam portions described and illustrated below, and like the damportions, comprises a single piece or a plurality of pieces, and similarmaterials. The cover is permanently or temporarily secured, for example,using adhesive, pressure sensitive adhesive, mechanical fasteners,clips, clamps, friction fittings, hook-and-loop fasteners, snaps, ties,screws, latches, and the like. In some embodiments, the cover comprisesone or more pockets dimensioned to receive one or more of the shapeablemembers 272 therein. In some embodiments, one or more portions of thecover are removable by a user, for example, by cutting or tearing.

FIG. 3 is a perspective view of an embodiment of a surgical accessdevice 300 generally similar to the embodiment discussed above. Theaccess device 300 comprises a proximal end 302, a distal end 304, alongitudinal axis 306, an access channel 308, a wound retractor 350disposed at the proximal end 302, and an adjustable internal retractor370 disposed at the distal end 304. The wound retractor 350 is generallysimilar to the embodiment of the wound retractor 250 described above,and comprises an outer ring 352, an inner ring 354, and a flexiblesheath 356. The internal retractor 370 is integrated with the woundretractor 350 or manufactured as a separate component, which ispreattached to the wound retractor 350 or user attached, or used withoutcoupling to a wound retractor, as discussed above.

The illustrated embodiment of the internal retractor 370 comprises aplurality of longitudinally extending inflatable supporting members 372and a plurality of dam portions 374 extending between adjacentsupporting members 372. In other embodiments, a single dam portion 374extends across a plurality of inflatable supporting members 372. Theillustrated embodiment also comprises a peripheral ring 376. In someembodiments, the peripheral ring 376 is fluidly connected to at leastone supporting member 372, and consequently, is inflatable with the atleast one supporting member 372. In other embodiments, the peripheralring 376 is not inflatable. In some embodiments, the peripheral ring 376comprises a plurality of linked members, for example, ball-and-socketsegments. In the illustrated embodiment, the internal retractor 370 isgenerally frustoconical in an inflated state, diverging distally fromthe longitudinal axis 304.

In the illustrated embodiment, the internal retractor 370 comprises anopen area or window 378, which permits access to tissue and/or organsoutside the perimeter of the internal retractor 370. The open area orwindow 378 allows a surgeon to place instruments and/or a hand intoareas above, to the side of, and/or below the internal retractor 370,which is useful, for example, when working in the lower abdomen orpelvis. Some embodiments comprise a plurality of open areas or windows378. Some embodiments of the internal retractor 370 do not comprise anopen area or window. In some embodiments, the internal retractor 370 issupplied without an open area or window 378, and the user creates one ormore as desired, for example, by removing selected dam portions 374. Insome embodiments, the spacing of the supporting members 370 is notuniform, thereby permitting a user to select a desired size of the openarea or window 378.

Embodiments of the internal retractor 370 comprise at least one ofrubber, polymer resin, fabric, foam, and elastomer. In some embodiments,the supporting members 372, the dam portions 374, and the peripheralring 376 comprise different materials. Some embodiments of the damportions 374 comprise at least one of polymer, membrane, film, rubber,webbing, gauze, film, fabric, woven fabric, non-woven fabric, and knitfabric. In some embodiments, the dam portions 374 comprise anelastomeric or stretchable material, for example spandex. Someembodiments of the internal retractor 370 further comprise at least oneflexible reinforcing member, for example, one or more ribs disposed on,through, or within at least one supporting member 372, dam portion 374,and/or the peripheral ring 376. In some embodiments, at least onesupporting reinforcing member 372 is elastically deformable. In someembodiments, at least one supporting member 372 is plasticallydeformable. Suitable materials for the supporting member are describedabove. Suitable materials for the reinforcing members 372 include atleast one of metal, a super elastic material, a shape memory material,polymer, fibers, and composites thereof. In some embodiments, thereinforcing members comprise at least one of wires, strips, bands, andthe like.

In some embodiments, a retraction and/or retention force that theinternal retractor 370 exerts on internal organs depends on the degreeof inflation thereof. Consequently, the retraction and/or retentionforce is adjustable by the end user. Embodiments of the internalretractor are inflatable with gas, carbon dioxide, nitrogen, air,liquid, water, saline, Ringer's solution, isotonic solutions, and thelike. In some embodiments, the inflation fluid is cooled and or heatedas desired.

FIG. 4 is a perspective view of another embodiment of a surgical accessdevice 400 that is generally similar to the embodiments discussed above.The access device 400 comprises a longitudinal axis 406 extending from aproximal end 402 to a distal end 404, an access channel 408 extendingthrough the device 400, a wound retractor 450 at the proximal end 402,and an adjustable internal retractor 470 at the distal end 404. Thewound retractor 450 is generally similar to the embodiments of the woundretractor described above, and comprises an outer ring 452, an innerring 454, and a flexible sheath 456. Embodiments of the internalretractor 470 are integrated, preattached, or user attached to the woundretractor 450, or used without coupling to a wound retractor, asdiscussed above.

In the illustrated embodiment, the internal retractor 470 comprises aplurality of individual segments 472 arrayed in a fan-likeconfiguration. In the illustrated embodiment, each segment 472 anglesaway from the longitudinal axis 406. At least some of the segments 472are slidably coupled to a hub 480, thereby defining an iris-like orfolding-fan structure, there by allowing a user to adjust an opening orwindow 478 in the internal retractor as desired, thereby adjusting thedegree of retention and/or retraction of internal organs. In theillustrated embodiment, the hub 480 comprises one or more tracks inwhich a proximal end of at least some segments 472 is slidably coupled.In some embodiments, the internal retainer 470 comprises a one-waymechanism that permits opening in one direction, only. In someembodiments, at least a portion of some of the segments 472 is malleableor plastically deformable. In the illustrated embodiment, a flexiblecover or dam 474 similar to the cover or dam described above, isdisposed over one or more of the segments 472.

FIG. 5 illustrates in a perspective view another embodiment of asurgical access device 500 that is generally similar to the embodimentsdescribed above. The surgical access device 500 comprises a longitudinalaxis 506 extending from a proximal end 502 to a distal end 504, anaccess channel 508 extending through the device 500, a wound retractor550 disposed at the proximal end 502 and an internal retractor 570disposed at the distal end 504. The wound retractor 550 is generallysimilar to the embodiments of the wound retractor described above, andcomprises an outer ring 552, an inner ring 554, and a flexible sheath556. Embodiments of the internal retractor 570 are integrated,preattached, or user attached to the wound retractor 550, or usedwithout coupling to a wound retractor, as discussed above.

The internal retractor 570 comprises a distally extending skirt member574 and a support member 576 coupled to a distal portion of the skirtmember 574. Embodiments of the skirt member 574 comprise any material asdiscussed above for the cover or dam portion. Embodiments of the supportmember 576 comprise one or more of elastic, malleable, and/orplastically deformable portions, for example comprising one or more ofthe materials described above. In the illustrated embodiment, thesupport member 574 comprises an inwardly extending projection 582defining and extending over an undercut or hollow portion 584, whichprovides the support member 574 with shape-memory characteristics. Inother embodiments, the support member 574 comprises a plurality oflinked members, for example, ball-and-socket segments.

The illustrated embodiment also comprises a window 578. In someembodiments, the window 578 is preformed. In others, the window 578 isuser created. In the illustrated embodiment, the window 578 includes agap in the support member 576. In other embodiments, the window 578extends only through the skirt member 574 and does not comprise a gap inthe support member 576.

FIG. 6A is a perspective view of another embodiment of an access device600 that is generally similar to the embodiments described above. Thesurgical access device 600 comprises a longitudinal axis 606 extendingfrom a proximal end 602 to a distal end 604, an access channel 608extending through the device 600, a wound retractor 650 disposed at theproximal end 602 and an internal retractor 670. The wound retractor 650is generally similar to the embodiments of the wound retractor describedabove, and comprises an outer ring 652, an inner ring 654, and aflexible sheath 656. Embodiments of the internal retractor 670 areintegrated, preattached, or user attached to the wound retractor 650, orused without coupling to a wound retractor, as discussed above.

The internal retractor comprises a tubular skirt 674 coupled to thewound retractor 650 and a retention ring 676 coupled to the free end ofthe skirt 674. In the illustrated embodiment, a diameter of theretention ring 676 is larger than a diameter of the outer ring 652 orthe inner ring 654. In the illustrated embodiment, the tubular skirt 674is coupled to the distal end of the wound retractor 650, for example,the inner ring 654. In other embodiments, the tubular skirt 674 iscoupled to the proximal end of the of the wound retractor 650, forexample, the outer ring 652. The skirt 674 comprises any suitableflexible material, for example, the materials described above for thecover or dam portion. The retention ring 676 comprises a malleable,deformable, shapeable, plastically deformable, and/or elasticallydeformable material, for example any of the materials described above.Some embodiments of the retention ring 676 comprise an internalmalleable or plastically deformable spine. Some embodiments comprise aplurality of linked members, for example, ball-and-socket segments.Consequently, some embodiments of the retention ring are shapeable in aplane or in all directions.

The illustrated embodiment of the internal retractor 670 does notcomprise a window. In some embodiments, one or more windows arepreformed in the skirt 674. In some embodiments, a user creates windowsin the skirt 674 as desired.

The internal retractor 670 is illustrated in an undeployed state in FIG.6A with the retention ring 676 is disposed proximally of the outer ring652 of the wound retractor 650, with the skirt 674 extending through theaccess channel 608. FIGS. 6B-6C illustrate a intermediate states inconverting the internal retractor 670 from the undeployed state orconfiguration illustrated in FIG. 6A, to a deployed state orconfiguration illustrated in FIG. 6D in which the retention ring 676 isdistal of the inner ring 654. In the illustrated method, the retentionring 676 is passed through the access channel 606 through the woundretractor 650. In the conversion process, the large-diameter retentionring 676 is squeezed, twisted, and/or otherwise deformed to a size thatfits through the access channel 608. In the deployed state orconfiguration illustrated in FIG. 6D, the large-diameter retention ring676 is shaped and/or adjusted to retract the internal organs from adesired area in the body cavity. For example, in some embodiments, theretention ring 676 is nested beneath internal structures 30 (FIGS.1B-1D), where the weight of the structures 30 secures the retention ring676 in place.

FIG. 7 illustrates in perspective view another embodiment of a surgicalaccess device 700 that is generally similar to the embodiments describedabove. The surgical access device 700 comprises a longitudinal axis 706extending from a proximal end 702 to a distal end 704, an access channel708 extending through the device 700, a wound retractor 750 disposed atthe proximal end 702 and an internal retractor 770. The wound retractor750 is generally similar to the embodiments of the wound retractordescribed above, and comprises an outer ring 752, an inner ring 754, anda flexible sheath 756. Embodiments of the internal retractor 770 areintegrated, preattached, or user attached to the wound retractor 750, orused without coupling to a wound retractor, as discussed above.

In the illustrated embodiment, the internal retractor 770 comprises aproximal, short tubular skirt 774 coupled to a distal, inflatable torus776. Some embodiments of the internal retractor 770 do not comprise askirt. In the undeployed state, the torus 776 is uninflated, while inthe deployed state, the torus 776 is selectively inflated. Someembodiments of the skirt 774 and/or torus 776 comprise stiffening orreinforcing members.

FIG. 8 is a perspective view of another embodiment of an access device800 that is generally similar to the embodiments described above. Thesurgical access device 800 comprises a longitudinal axis 806 extendingfrom a proximal end 802 to a distal end 804, an access channel 808extending through the device 800, a wound retractor 850 disposed at theproximal end 802 and an internal retractor 870. The wound retractor 850is generally similar to the embodiments of the wound retractor describedabove, and comprises an outer ring 852, an inner ring 854, and aflexible sheath 856. Embodiments of the internal retractor 870 areintegrated, preattached, or user attached to the wound retractor 850, orused without coupling to a wound retractor, as discussed above.

In the illustrated embodiment, the internal retractor 870 comprises agenerally hollow cylinder or tube with open ends through which theaccess channel extends. In other embodiments, the internal retractor 870has another shape, for example, an elliptical cylinder, or frustoconicalwith the larger end distal or with the smaller end distal. Embodimentsof the internal retractor 870 are manufactured in a range of diametersand/or lengths. The internal retractor 870 is elastically deformable orplastically deformable. In some embodiments, one or more portions of theinternal retractor 870 are elastically deformable and one or moreportions are plastically deformable. Plastically deformable portionspermit a user to shape the internal retractor 870 as desired. Theinternal retractor 870 is sufficiently deformable radially to permitinsertion through an incision and/or the wound retractor 850.

In the illustrated embodiment, the internal retractor 870 comprises aplurality of stacked, annular segments 872. In the illustratedembodiment, the annular segments 872 are toroidal; however, in otherembodiments, the annular segments have other shapes and/or a mixture ofshapes. In some embodiments, the annular segments are detachable orseparable from each other, for example, by cutting or tearing, whichpermits a user to adjust a length of the internal retractor. Someembodiments of the internal retractor 870 are separable longitudinally,for example, using one or more partial or complete longitudinal cuts,which permits a user to generate openings or windows as desired. Someembodiments of the internal retractor 870 further comprise a complete orpartial cover, as discussed above.

In some embodiments, the internal retractor 870 is coupled to the woundretractor 850 such that the internal retractor 870 is translatable,thereby permitting the user to isolate a surgical field that is notdirectly below the wound retractor 850. In use, the wound retractor 850is well anchored to a patient, thereby anchoring the internal retractor870. Suitable coupling devices are known in the art, for example, rods,bars, clamps, clips, swivels, hinges, and the like. In some embodiments,the internal retractor 870 is not coupled to the wound retractor 850.

FIG. 9 is a perspective view of another embodiment of an internalretractor 970, which is similar to the embodiments described above. Theinternal retractor 970 is integrated with, couplable with, used with, orused independently of a wound retractor, as discussed above. Theillustrated embodiment of the internal retractor 970 comprises alongitudinal axis 906, an access channel 908, and a serpentine frame 972defining a hollow cylinder or tube. In other embodiments, the frame 972defines a different shape, for example, frustoconical or an ellipticalcylinder. The serpentine frame 972 defines a plurality ofcircumferential voids or openings 982 in the cylindrical surface intowhich circumferential fingers 984 defined by the frame 972 interleavewhen the frame 972 is compressed radially, for example, when insertingthe internal retractor 970. Those skilled in the art will understandthat in other embodiments, the serpentine frame 972 has a differentshape that defines voids 982 and fingers 984 with different shapes. Theframe 972 comprises a plastically deformable material, an elasticallydeformable material, or a combination thereof. In embodiments comprisinga plastically deformable material, the internal retractor 970 isreshapeable or adjustable on deployment.

In the illustrated embodiment, the internal retractor 970 furthercomprises a cover or dam portion 974, as discussed above. In someembodiments, the cover is cuttable through a void area 986, whichpermits further adjustment in the deployed state. Other embodiments donot comprise a cover or dam portion.

FIG. 10A is a perspective view of another embodiment of an internalretractor 1070, which is similar to the embodiments described above. Theinternal retractor 1070 is integrated with, couplable with, used with,or used independently of a wound retractor, as discussed above. Theillustrated embodiment of the internal retractor 1070 comprises alongitudinal axis 1006, an access channel 1008, and a serpentine frame1072 defining a hollow cylinder or tube. In other embodiments, the frame1072 defines a different shape, for example, frustoconical or anelliptical cylinder. The serpentine frame 1072 defines a plurality oflongitudinal voids or openings 1082 in the cylindrical surface, whichpermit a user to compress the frame 1072 radially, for example, wheninserting the internal retractor 1070. Those skilled in the art willunderstand that in other embodiments, the frame 1072 comprises aplurality of longitudinal members instead of a single serpentine orsinuous member. The frame 1072 comprises a plastically deformablematerial, an elastically deformable material, or a combination thereof.In embodiments comprising a plastically deformable material, theinternal retractor 1070 is reshapeable or adjustable on deployment.

The illustrated embodiment further comprises a distal support member1076 disposed at a distal end of the internal retractor 1070. Asillustrated in FIG. 10B in an undeployed state, the internal retractor1070 is conical. In deploying the internal retractor 1070, the distalsupport member 1076 is advanced along the access channel 1008 until itengages a distal end of the frame 1072, for example in a set of hooks1086, as shown in FIG. 10C.

Some embodiments of the internal retractor 1070 comprise a cover or damportion (not illustrated). Some embodiments are openable, for example,by cutting the distal support member 1076, if present, or portions ofthe frame 1072, which permits additional adjustability.

FIG. 11 is a perspective view of another embodiment of an internalretractor 1170, which is similar to the embodiments described above. Theinternal retractor 1170 is integrated with, couplable with, used with,or used independently of a wound retractor, as discussed above. Theillustrated embodiment of the internal retractor 1170 comprises alongitudinal axis 1106, an access channel 1108, and a lattice frame 1172defining a hollow cylinder or tube. In other embodiments, the frame 1172defines a different shape, for example, frustoconical or an ellipticalcylinder. The lattice frame 1172 defines a plurality of voids oropenings 1182 in the cylindrical surface, which permit a user tocompress the frame 1172 radially, for example, when inserting theinternal retractor 1170. In the illustrated embodiment, the frame 1172comprises a diamond lattice. In other embodiments, the frame 1172comprises a different lattice, for example, a hexagonal lattice. Theframe 1172 comprises a plastically deformable material, an elasticallydeformable material, or a combination thereof. In embodiments comprisinga plastically deformable material, the internal retractor 1170 isreshapeable or adjustable on deployment.

In the illustrated embodiment, the internal retractor 1170 furthercomprises a cover or dam portion 1174, as discussed above. Otherembodiments do not comprise a cover or dam portion. Some embodiments areopenable, for example, by cutting portions of the frame 1172, whichpermits additional adjustability.

FIG. 12 is a perspective view of another embodiment of an internalretractor 1270, which is similar to the embodiments described above. Theinternal retractor 1270 is integrated with, couplable with, used with,or used independently of a wound retractor, as discussed above. Theillustrated embodiment of the internal retractor 1270 comprises alongitudinal axis 1206 extending between a proximal end 1202 and adistal end 1204, a deformable frame 1272, and a cover or dam portion1274. The illustrated embodiment also comprises a connection feature1280, which permits coupling the internal retractor 1270 to a woundretractor, as discussed above. In the illustrated embodiment, the frame1272 defines a generally rectangular internal retractor 1270. In otherembodiments, the frame 1272 defines a different shape, for example,trapezoidal or rhomboidal. The frame 1272 is serpentine in theillustrated embodiment. In other embodiments, the frame 1272 has adifferent structure, for example, a lattice, a mesh, a solid sheet, aperforated sheet, or a combination of structures. The frame 1272comprises a plastically deformable material, an elastically deformablematerial, or a combination thereof. In embodiments comprising aplastically deformable material, the internal retractor 1270 isreshapeable or adjustable on deployment.

In the illustrated embodiment, the internal retractor 1270 furthercomprises a cover or dam portion 1274, as discussed above. Otherembodiments do not comprise a cover or dam portion. Some embodiments arereshapeable, for example, by cutting portions of the frame 1272 and/orcover 1274, which permits additional adjustability.

FIG. 13A illustrates a side view another embodiment of a surgical accessdevice 1300 that is generally similar to the embodiments describedabove. The surgical access device 1300 comprises a longitudinal axis1306 extending from a proximal end 1302 to a distal end 1304, an accesschannel 1308 extending through the device 1300, a wound retractor 1350disposed at the proximal end 1302 and an internal retractor 1370. Thewound retractor 1350 is generally similar to the embodiments of thewound retractor described above, and comprises an outer ring 1352, aninner ring 1354, and a flexible sheath 1356. Embodiments of the internalretractor 1370 are integrated, preattached, or user attached to thewound retractor 1350, or used without coupling to a wound retractor, asdiscussed above.

As best seen in the detailed view in FIG. 12B, the internal retractorcomprises a body 1372 comprising a groove 1380 extending at leastpartially along a proximal edge thereof, which is dimensioned to receivethe inner ring 1354 of the wound retractor 1350 therein. The body 1372comprises a plastically deformable material, an elastically deformablematerial, or a combination thereof. In embodiments comprising aplastically deformable material, the body 1372 is reshapeable oradjustable on deployment. In some embodiments, the body 1372 is tubularand dimensioned to the diameter of the inner ring 1354. In otherembodiments, the body 1372 is supplied as an elongate strip. In eithercase, some embodiments of the body 1372 may be trimmed as desired.

In the illustrated embodiment, a connection feature 1388 extends atleast partially along the distal edge of the body 1372. As best seen inthe perspective view in FIG. 13C, the connection feature 1388 of thebody 1372 couples to an extender 1390, which comprises a complementaryconnector 1392 a extending at least partially along a proximal edge ofthe extender 1390. In the illustrated embodiment, the connection feature1388 and the complementary connector 1392 a are self-complementary, thatis, have the same shape. As with the body 1372, the extender 1390comprises an elastically deformable material, plastically deformablematerial, or a combination thereof. In the illustrated embodiment, theextender 1390 further comprises a second complementary connector 1392 bdisposed along at least a portion of a distal edge of the extender 1390,which permits a user to add as many extenders 1390 as desired.Consequently, in the illustrated embodiment, the internal retractor 1370comprises the body 1372 and any number of extenders 1390 desired.

In other embodiments, the connection feature 1388 has the samecross-sectional shape as the inner ring 1354 of the wound retractor1350. Consequently, the body 1372 is also an extender in theseembodiments.

FIG. 14 is a perspective view of another embodiment of an internalretractor 1470, which is similar to the embodiments described above. Theillustrated embodiment of the internal retractor 1470 comprises alongitudinal axis 1406 extending between a proximal end 1402 and adistal end 1404, an access channel 1408, and a plurality of shapeablemembers 1472. The shapeable members are similar to the shapeable members272 described above, except that the shapeable members 1472 of theillustrated embodiment are coupled to an outer ring 1452 of a woundretractor rather than an inner ring.

In the illustrated embodiment, the proximal end of each shapeable member1472 comprises a connection feature 1480 that couples the shapeablemember 1472 to the outer ring 1452. The illustrated configurationpermits a user to determine the number and spacing of shapeable members1472 used in any particular situation. In one embodiment, the userinserts a distal end of the shapeable member 1472 through the accesschannel 1408, then couples the shapeable member 1472 to the outer ring1452.

In other embodiments, one or more shapeable members 1472 are deployed asa unit, for example, comprising a common connection feature 1480. Insome embodiments comprising a common connection feature 1480, theshapeable members 1472 are substantially longitudinal or convergent wheninserted through the access channel 1408, then reshaped after couplingto the outer ring 1452.

FIG. 15 is a perspective view of another embodiment of an internalretractor 1570, which is similar to the embodiments described above. Theillustrated embodiment of the internal retractor 1570 comprises alongitudinal axis 1506 extending between a proximal end 1502 and adistal end 1504, an access channel 1508, and a plurality of shapeablemembers 1572. The shapeable members are similar to the shapeable members272 and described above, except that the shapeable members 1572 of theillustrated embodiment are coupled to an outer ring 1552 of a woundretractor rather than an inner ring.

In the illustrated embodiment, an arcuate base 1580 releasably mateswith the outer ring 1552. In other embodiments, the connection featurehas a different arc length, for example, a full circle. The base 1580comprises a connector 1582 that couples to the shapeable members 1572.In the illustrated embodiment, the connector 1582 comprises a T-trackinto which is received a complementary portion disposed at a proximalend of each shapeable member 1472. Those skilled in the art willunderstand that other embodiments use connectors with otherconfigurations, for example, rails, tracks, holes, posts, and the like.In the illustrated embodiment, the connector 1582 is disposed along aninner surface of the base. In other embodiments, the connector isdisposed on another surface, for example, a proximal face, an outerface, or a face at another angle to the longitudinal axis 1506. Theshapeable members 1572 are slidable along the T-track. The T-trackcomprises a gap 1584 dimensioned to permit a user to insert or removeshapeable member therethrough. The illustrated configuration permits auser to determine the number and spacing of shapeable members 1572 usedin any particular situation. In one embodiment, the user couples thebase 1580 to the outer ring 1552, inserts a distal end of the shapeablemember 1572 through the access channel 1508, aligns the shapeable memberwith the gap 1584, then couples the shapeable member 1572 to theconnector 1582.

An embodiment of a method for using a surgical access device inabdominal surgery is schematically illustrated in FIGS. 16A-16C anddescribed with reference to the embodiment of the access device 300illustrated in FIG. 3, although one skilled in the art will understandthat the method is also applicable to all of the embodiments of theaccess device described herein. FIG. 16A is a side, partial crosssection of a patient in which a wound retractor 350 has been placedthrough a body wall 40 and into a body cavity 42, which is an abdominalcavity in this case. The inner ring 354 and internal retractor 370 arefirst inserted through an incision in the body wall 40 into the bodycavity 42. The outer ring 352 is then inverted through or rotated arounditself, thereby winding the tubular sheath 356 around the outer ring352, thereby retracting the incision. In some embodiments, the outerring 352 of the proximal portion is easily invertible in a snap-overmotion, which provides a neutral position that resists rotation undertension generated in the retraction process. The tension secures theretractor 350 to the body wall 40.

In the illustrated embodiment, the abdominal cavity 42 is inflated withgas, thereby facilitating access to internal structures 30. In someembodiments, a cap or cover (not illustrated) is secured to the proximalportion of the retractor 350, thereby creating a substantially gas-tightclosure to the body cavity 42, after which, the body cavity 42 isinflated or insufflated, for example, with CO₂ gas.

The internal retractor 370 is then deployed as desired within the bodycavity 42, thereby retracting or retaining internal structures duringthe surgical procedure. FIG. 16A illustrates the surgical site 70 beforedeploying the internal retractor 370. For example, in the illustratedprocedure, the position of abdominal content 30 is adjusted for anoperation below the small intestine 32. FIG. 16B illustrates a frontpartial cross section and FIG. 16C illustrates a side partial crosssection of a retention pattern in which the internal retractor 370 holdsthe small intestine 32 away from the operative site 70.

In the illustrated embodiment, deploying the internal retractor 370comprises positioning the peripheral ring 376 of the internal retractor370, and inflating the inflatable supporting member 372 to a desirestate of retention or retraction of the internal structures 30. Theinflated internal retractor 370 dams or walls-off loose structures fromthe operative site 70. In inserting the access device 300, as well as indeploying the internal retractor 370, the internal retractor 370 ismanipulated manually and/or with an instrument. For example, in someembodiments, the access device 300 is dimensioned and configured foraccess to the body cavity 22 by a surgeon's hand 100 through the orificeaccess channel 608 of the access device 300. Other embodiments use asmaller access device 300 that is sized and configured to acceptsurgical instruments, such as laparoscopic tools, therethrough, but nota hand. In some cases, using a single, smaller device 300 limits thenumber of incisions needed in a laparoscopic procedure. Those skilled inthe art will understand that the particular deployment procedure for theextendable member differs for each embodiment described above.

While certain embodiments have been particularly shown and describedwith reference to exemplary embodiments thereof, it will be understoodby those of ordinary skill in the art that various changes in form anddetails may be made therein without departing from the spirit and scopethereof as defined by the following claims.

What is claimed is:
 1. A surgical access device comprising: a proximalend, a distal end, a longitudinal axis extending from the proximal endto the distal end, and an access channel extending therethrough; a woundretractor comprising an outer ring, an inner ring, and a tubular sheathextending between the outer ring and the inner ring; and an internalretractor that retracts nearby objects, wherein the internal retractorcomprises one or more shapeable members, wherein each shapeable memberhas connective features that connects the shapeable member to the woundretractor, and wherein each of the shapeable members connected to thewound retractor are removable.
 2. The surgical access device of claim 1,wherein each of the shapeable members are inflatable with gases orliquids.
 3. The surgical access device of claim 2, wherein a dam portionextends between two adjacent shapeable members, the dam portionproviding further retraction capabilities to retract nearby objects inconnection with the one or more shapeable members.
 4. The surgicalaccess device of claim 3, wherein at least a portion of the dam portionis removable from between two adjacent shapeable members to create anopen area or window.
 5. The surgical access device of claim 1, whereinthe wound retractor includes a hub where each of the one or moreshapeable members are connected, and wherein the hub includes tracksthat allow adjustment of a degree of retention/retraction for each ofthe one or more shapeable members associated with the internalretractor.
 6. The surgical access device of claim 5, wherein the tracksassociated with the hub permit the one or more shapeable members to openin one direction
 7. The surgical access device of claim 5, wherein thetrack is disposed around a circumference of the wound retractor, andwherein the track permits the one or more shapeable members to bepositioned along the circumference via sliding along the track.
 8. Thesurgical access device of claim 1, wherein the one or more shapeablemembers are deformable.
 9. The surgical access device of claim 1,wherein two or more of the shapeable members are connectable to thewound retractor as one unit.
 10. The surgical access device of claim 1,wherein a retention ring is attached to ends of the one or moreshapeable members of the internal retractor, wherein the retention ringis disposed proximally of the outer ring of the wound retractor in anundeployed state, wherein converting the internal retractor from theundeployed state to a deployed state requires the retention ring to passthrough the wound retractor, and wherein the retention ring is disposeddistally of the outer ring of the wound retractor in a deployed state toretract object in a desired area.